Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system.
This recall has been terminated (originally issued September 22, 2009).
- Recall Initiated
- July 17, 2009
- Posted
- September 22, 2009
- Terminated
- November 27, 2010
- Recall Number
- Z-2231-2009
- Quantity
- 1
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.
Distribution
Product was distributed to one user in Texas
Lot / Code Info
Model number H48, code number H484023.
Root Cause
Software design
Action Taken
Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned.
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